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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies
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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH


WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            
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To sort by data column: 26 orders  
  Active Orders
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Sort By 522 Order Number 522
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Sort By Date 522 Order Date 522
Order		 Sort By Date 522 Order -- Descending
Study
Name
Date Original
Plan
Accepted
Study Status
PS120001 Acell, Inc. Acell matristem pelvic floor matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry 09/08/2013 Progress Adequate
PS140001 Argo Medical Technologies, Inc Rewalk Neurology 06/26/2014 ReWalk Registry 05/05/2016 Progress Inadequate
PS200001 Avenu Medical, Inc. Ellipsys vascular access system 01/10/2020 Ellipsys Vascular Access System PS Study Plan Pending
PS160001 Bayer Healthcare, LLC Essure system for permanent birth control Obstetrics/
Gynecology		 02/29/2016 Postmarket Surveillance Study 09/02/2016 Progress Adequate
PS200004 Bluegrass Vascular Technologies, Incorporated Surfacer inside-out access catheter system 02/10/2020 Postmarket Surveillance Study Plan Pending
PS120081 Boston Scientific Xenform soft tissue repair matrix General &
Plastic Surgery		 01/03/2012 POP AE and Effectiveness rates, registry 09/27/2013 Progress Adequate
PS130044 Boston Scientific Corporation Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold Obstetrics/
Gynecology		 07/03/2013 POP AE and Effectiveness rates, registry 09/10/2013 Progress Adequate
PS200005 Caldera Medical, Inc. Desara One Single Incision Sling System 02/11/2020 Postmarket Surveillance Study Plan Pending
PS130039 Coloplast Corp Altis single incision sling system Gastroenterology/
Urology		 03/13/2013 AE and effectiveness rates 12/06/2013 Progress Adequate
PS120106 Coloplast Corp. Restorelle polypropylene mesh General &
Plastic Surgery		 04/09/2012 POP AE and Effectiveness rates, registry 05/17/2013 Progress Adequate
PS150002 Fujifilm Medical Systems USA, Inc. Fujifilm duodenoscopes Gastroenterology/
Urology		 10/05/2015 Sampling and Culturing Study 12/21/2016 Noncompliant
PS190002 FUJIFILM Medical Systems, U.S.A., Inc. Duodenoscope 08/28/2019 Sampling and Culturing 12/06/2019 Study Pending
PS110038 Johnson and Johnson Depuy pinnacle metal-on-metal acetabular cup liners Orthopedic 05/06/2011 Explant Analysis 07/06/2012 Progress Adequate
PS110070 MicroPort Metal transcend articulation system Orthopedic 05/06/2011 Metal Ion Levels Microport 01/30/2017 Progress Inadequate
Explant 03/21/2017 Progress Inadequate
Metal Ion Levels Wright 11/01/2012 Revised/Replaced Study
PS110002 Nexus CMF Tmj fossa-eminence/condylar prosthesis system Dental 02/04/2011 Registry Database 08/23/2013 Revised/Replaced Study
TMJ Fossa-Eminence and Condylar Pros 02/04/2011 Revised/Replaced Study
TMJ Registry Study - Total Revised/Replaced Study
TMJM Registry Study - Partial Revised/Replaced Study
Prospective Postmarket Surveillance Study Plan 02/04/2011 Progress Inadequate
Explant Analysis Study Plan 02/04/2011 Progress Adequate
PS200002 Olympus America, Inc. Evis Exera III Duodenovideoscope TJF-Q190V Gastroenterology/
Urology		 01/17/2020 Human Factors Study Plan Pending
PS200003 Olympus America, Inc. Evis exera iii duodenovideoscope tjf-q190v Gastroenterology/
Urology		 01/17/2020 Sampling and Culturing Study Plan Pending
PS150003 Olympus Medical Systems Corporation (OMSC. Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Sampling and Culturing Study 11/22/2016 Noncompliant
PS160003 Parker Hannifin Corporation Indego Neurology 04/15/2016 Indego Postmarket Surveillance Study 10/07/2016 Progress Inadequate
PS150004 Pentax Medical Duodenoscopes Gastroenterology/
Urology		 10/05/2015 Sampling and Culturing Study 12/08/2016 Progress Adequate
PS190005 Pentax of America, Inc. Pentax duodenoscope model ed34-il0t2 Gastroenterology/
Urology		 11/15/2019 Sampling and Culturing Study Plan Pending
PS150001 Preceptis Hummingbird tympanostomy tube system Ear Nose & Throat 04/23/2015 Post-market Surveillance Study (PSS) 04/23/2015 Progress Inadequate
PS190001 Rapid-Medical, Ltd. Comaneci embolization assist device 05/22/2019 PSS Plan Pending
PS120111 St. Jude Medical, Inc. Riata, quicksite, quickflex, durata Cardiovascular 08/16/2012 Lead Externalization and Abrasion 02/22/2013 Progress Adequate
PS190006 Tandem Diabetes Co. Control-iq, algorithm 12/13/2019 Postmarket Surveillance Study Plan Pending
PS110003 TMJ Concepts Patient-fitted tmj reconstruction prosthesis system Dental 02/04/2011 Time to Revision and Explant Analysis 01/13/2012 Progress Adequate


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov
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